Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.
Odevixibat is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes also referred to as the apical sodium dependent bile acid transporter (ASBT), that has minimal systemic exposure at therapeutic doses and acts locally in the gut.
Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC. The Company intends to complete regulatory filings in the EU and in the U.S. no later than early 2021, in anticipation of potential regulatory approval, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021, if approved. The Company also plans to initiate a pivotal Phase 3 trial of odevixibat in Alagille syndrome by the end of 2020, and to continue enrolling patients in the BOLD pivotal Phase 3 trial of odevixibat in biliary atresia. Albireo continues to progress its pipeline and expects to complete IND-enabling studies for a new preclinical candidate this year.
The U.S. Food and Drug Administration (FDA) has granted to the odevixibat PFIC program or elements of it fast track, rare paediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted odevixibat orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Its Paediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA also have granted orphan drug designation to odevixibat for the treatment of Alagille syndrome and primary biliary cholangitis. Albireo will commercialise Odevixibat in the US, Europe & Canada and will partner in remaining regions.
Job Title: Senior Associate, Regulatory Operations
Location: Boston, MA
We are seeking an experienced, in-house Regulatory Operations professional who can assist with a variety of submissions and records management activities with limited supervision. In this position, you will participate in various activities as part of a dynamic and evolving Regulatory Operations team. The Senior Associate must be a creative, resourceful, integrative thinker.
Key Duties and Responsibilities:
Independently prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and NDA/MAA applications
Format MS Word and Adobe Acrobat files to a state of submission-readiness
Act as department liaison to publishing and archival vendors
Provide support to Regulatory Affairs and other project stakeholders in the creation of submissions documents
Manage and maintain correspondence and other records in regulatory tracking system
Coordinate exchange of records using document-sharing platforms
Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements
Maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes related to the electronic Common Technical Document.
Expert-level document formatting and submission building (eCTD and non-eCTD)
Expert-level knowledge of PDF Publishing tool (ToolBox preferred)
Proficiency in Microsoft Word, Microsoft Excel, Adobe Acrobat Professional, and Sharepoint
Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
Excellent organization, written/verbal communication, and attention to detail
Grouped and OPDP Submission experience
3 to 5 years of relevant Regulatory Operations experience in biotech/pharmaceutical industry
Strong understanding of submission requirements, records management concepts, and electronic tools and systems.
Bachelor’s degree or equivalent experience
Equal Opportunity Employer
All applicants should be legally entitled to work for any employer in the U.S.
Note to employment agencies: Please do not forward any agency resumes.